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Medical Device
Compliance Experts
And Quality
Management System

Your experienced partner that is passionate about the medical device industry



MDR 2017/745

IVDR 2017/746




CE-marking process

Medical Device QMS

Effectively ensure regulatory compliance and exceed quality goals throughout your organisation enabling innovation to drive forwards

MedQtech is an experienced team of medical device regulatory and quality compliance specialists.
We partner with medical device companies to ensure a streamlined journey to compliance and to drive quality enhancement throughout an organisation – ensuring compliance and quality systems are not barriers but enablers. We offer a portfolio of services that we tailor to our customers’ needs:

Medical Device Consultancy

Providing our customers with a regulatory and quality service mix designed for the medical device industry

Medical Device
Regulatory Compliance


Our services include:

  • CE marking process
  • Regulatory applications and registrations (EU/US)
  • Classification of medical devices
  • Gap analysis
  • Regulatory strategy
  • Act as your Person Responsible for Regulatory Compliance (PRRC)
  • Project management
And other regulatory affairs support
Regulatory Compliance Services Medical Device Regulatory Consultants

Medical Device
Quality Management


Our services include:

  • Quality management system implementation
  • ISO13485 certification readiness
  • QSR (FDA) compliance
  • Facilitation of ISO14971 Risk management
  • Act as your Quality and Regulatory resource
  • Develop/maintain QMS processes
  • Project management
And other quality management support
Quality Management Services Medical Device Regulatory Consultants

Partner with MedQtech to achieve your
medical device goals effectively and efficiently

Effectively extend your team with experienced medical device regulatory compliance and quality management system specialists - accelerate your speed to market access.

Medical Device Consultants

Medical device focused

Medical Device Consultants

Quality/regulatory/audit/ risk management service

Medical Device Consultants

International compliance expertise (inc. EU & USA)

Medical Device Consultants

Focused on project delivery

Medical Device Consultants

Integrated eQMS

Medical Device Consultants

Full project management capability

Medical Device Consultants

Multi-eQMS skilled & enabled

Medical Device Consultants

Commercial goal aware


Medical Device Labelling

MDR lists some requirements for medical device labelling and instructions for use (IFU). Although they are requirements, you can also see them as guidance, helping you to not forget anything necessary or interesting for the user. This blog article gives a short introduction emphasizing some of the essentials in the regulation.

Tom Gärds
By Tom Gärds
Read more

How to classify a medical device according to MDR 2017/745

Unsure how to classify your medical device according to MDR 2017/745? In this blog article we provide an overview of the MDR medical device classes and classification rules.

Pontus Axblom
By Pontus Axblom
Read more

MedQdoc Quality Management System (eQMS)


An eQMS solution designed and validated for the medical device industry:

  • Over 130 ready-to-use templates
  • Simple step-by-step workflow
  • Designed by compliance experts
  • Cloud based flexibility
  • Accelerate your medical device compliance while enhancing your quality management system.

MedQdoc allows you to get your consultancy services and QMS system from the same provider.

“MedQtech have constructively guided us through both the quality and regulatory compliance processes. Their experience has ensured that compliance and quality are positive contributions and not distractions to our business. The result is that we accelerated our compliance journey and enhanced our business processes for the future”


Medical device company

Our Valued Clients